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Wednesday, 25 January 2012

When the Ravages of Time Contribute to Patent Infringement

In a recent decision published here, the Düsseldorf district court had to decide on a preliminary injunction requested based on a patent on a substance containing a mixture of two substances – Leflunomid and Teriflunomid. The claims required among other things that the amount of Teriflunomid should fall in a range between 0,3% and 50% of the amount of Leflunomid.

The allegedly infringing embodiments contained a priori only the first substance Leflunomid. However, the patentee argued that due to certain chemical processes occurring under regular storage conditions at a temperature of 25°C and a humidity of 60%, the amount of second substance Teriflunomid would increase and reach the threshold of 0,3% after 6 months for a first embodiment and after 9 months for a second embodiment.

The court found the product to infringe the patent directly and literally (no contributory infringement as one might have presumed). It referred to the earlier judgement with the title “Traktionshilfe” of the Düsseldorf Upper District Court (OLGDüsseldorf I-2 U 139/09) departing from the general rule according to which all the features of a claim must be realized in the moment of the use in cases where the circumstances will change in a reliable and predictable way such that the features of the claim will be realized soon (“demnächst”).

Interestingly, the Bundespatentgericht (BPatG) had rejected a novelty attack based on very similar arguments in the co-pending nullity procedure (which can be found here ). The BPatG found that even if the conversion of Leflunomid into Teriflunomid may actually have taken place under certain storage conditions prior to the priority date, this conversion was not the consequence of a methodical (planvoll) technical activity but rather uncontrolled such that the actual technical teaching to use product with a certain composition was not known. If achieving the claimed composition is the result of a certain choice of storage conditions and there is no evidence that this choice was actually made, the claimed composition is novel.

This highlights an important difference between the assessment of novelty and infringement which results from the focus on the technical idea rather than on the tangible features. According to the decision, a product may be infringing a patent accidentally, e.g. as the result of a natural decay/conversion process. If the same product (but not the decay process) was known before the priority date and the circumstances leading to the decay/conversion process are actually not inevitable, it would not be novelty destroying.

7 comments:

MaxDrei
said...

Ah-ha. An act coming afterwards is an infringing act. But exactly the same act, coming before the date of the claim, fails to destroy novelty. Dr Thesen, can you imagine the same judging panel (at the BGH in Karlsruhe, for example) looking simultaneously at both infringement and validity, on conjoined appeal from both OLG Duesseldorf (infringement) and BPatG Munich (validity), confirming that both of the decisions in Duesseldorf and Munich are correct?

I think that the discrepancy would be resolved at the BGH at the latest.

See e.g. the series "Crimpwerkzeug" decisions for an example where differing claim constructions have led to one judgement according to which a device was considered infringing and another judgement (of the PatG) where substantially the same device was considered not novelty destroying. Finally, the discrepancy had been resolved at the BGH (even though the appeals were handled by differing senates - please note that there is no such thing as a "conjoined appeal" - the infringement case remains formally independent from the validity case even at the BGH).

A part of the problem here might be that the courts had differing evidence.

Many thanks for that answer Michael. Looking again at your report, I see that the patentee's case at the District Court was that decay occurred at a RH of 60%. One would have thought that, in real life, the accused embodiment was actually stored dry, at a RH nowhere near 60%, so did not actually suffer decay. So, the BPatG finding that validity is not prejudiced by the 60% RH evidence of decay seems to me to be reasonable. However, on the same logic, the finding of infringement seems harsh.

But for the sake of this discussion, can we set aside the complexity of different evidence before different courts, and simplify the legal issue down to its essence. Suppose the claim is to a per se mixture of X + Y. Suppose that the undisputed fact, in both courts, is that a prior art product which is 100% X, when stored at room temperature under storage conditions that are standard for such drugs, decay is inevitable, to less than 100% X and a small but increasing amount of Y.

One would have thought that, because of the inevitability, the claim to X + Y per se does lack novelty over prior X but that, had it been valid, would be infringed by later sales of drug X per se.

On the same facts, I imagine a claim directed to the USE of X + Y being held both infringed and not invalid.

Could it be that the courts here, striving to get to the "right" result, were reading a product per se claim as if it were a use claim?

I did not digg into the chemical details of this case but it appears that the X-Y conversion process was not inevitable but rather dependent on the storage conditions.

The district court mentions that the defendant did not take any cuonter-measures (implying that such counter-measures exist - e.g. writing "keep at a dry place") and the BPatG asserted that the storage conditions inducing the X-Y conversion were actually chosen.

I am not a friend of this particular decision (which appears to interpret the precedent deciosn "Traktsionshilfe" wrongly. However, this result might be seen as a result of the differing standards to be applied. For a feature to be implicitly disclosed in the prior art, it is necessary that it is the inevitable consequence of putting the prior art to practice. A according to the case-law feature may be considered inherent for the question of infringement if it will be realized in the regular use (here: regular storage conditions) even if there are alternatives to that regular use such that it is not inevitable.

Thanks again. Your answer, contrasting what is "implicit" (validity) with what is "inherent" (for infringement), prompts me to suggest that German caselaw crash is what prompted the European Trademark Regulation to set it out explicitly, that the test for validity and the one for infringement shall be the same.

When we get separate track patent courts for infringement and validity, not only as now in Germany but also at a pan-European, supra-national level, with the CJEU (as opposed to the BGH) having the final word, will we all be scratching our heads over decisions like this one, I wonder.

Michael, don't get me wrong. I'm having a go at the Decisions, not you. I deeply appreciate your efforts to help me understand them.

In the end (looking at validity and infringement at the same time) things appear much easier: Since nobody was able to point to a stable prior art composition or to an art known method, by which the rearrangement could be avoided, the BGH came to the conclusion that the combination lacks novelty.

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